National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)
This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (https://dpcpsi.nih.gov/). All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by the National Institute of Mental Health (NIMH) on behalf of the NIH.
U24 Resource-Related Research Projects – Cooperative Agreements
None
RFA-RM-22-010 , UM1 Research Project with Complex Structure Cooperative Agreement
RFA-RM-22-011 , UG3/ UH3 Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II
RFA-RM-22-013 , UM1 Research Project with Complex Structure Cooperative Agreement
This Funding Opportunity Announcement (FOA) invites applications to establish the Tissue Procurement Center for the Somatic Mosaicism across Human Tissues (SMaHT) Network. The purpose of the SMaHT Network is to enable discovery of new biology and disease mechanisms mediated by genomic variation in somatic tissues. The goal of the Tissue Procurement Center is to collect, process, store, and rapidly distribute to the Network at least 15 high quality, well characterized, human tissues recovered from a minimum of 150 individuals recruited from a diverse pool of donors.
June 8, 2022
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| July 08, 2022 | Not Applicable | Not Applicable | November 2022 | January 2023 | April 2023 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Background
The genomics era has revolutionized medicine and biomedical research by uncovering the genetic basis of thousands of diseases, congenital birth defects, and biological processes. However, genetic studies, which rely on DNA primarily isolated from blood and saliva, fail to fully capture all DNA variation in affected cells, tissues, and organs, yielding an incomplete snapshot of somatic variations and their contribution to health and disease. Variants occur widely throughout the genome and across the lifespan via a variety of genomic and biological mechanisms, creating stochastic, clonal, and dynamic somatic mosaicism. Although small-scale studies show causal roles for somatic variants in development, aging processes, and several diseases, the functional consequences of somatic variation are largely unknown.
The purpose of the Somatic Mosaicism across Human Tissues (SMaHT) Network is to propel discovery of new biological processes in human health and disease that are mediated by genomic variation in somatic tissues. The role of somatic variants in human health will be elucidated through: 1) Building a scaffold and foundational datasets that catalog somatic variation across a set of common tissues from a diverse donor pool, 2) developing tools focused on increasing the sensitivity of detection and specificity of the pipelines to detect multiple types of variations, and 3) creating a variant catalog, portal and integrated workbench that facilitates access to the tools, technologies, and data developed by the Network.
Five initiatives will be used to achieve the goals of this NIH Common Fund program:
- The Tissue Procurement Center (TPC) will collect, process, and distribute a set of 10-15 high quality human tissues from a diverse donor cohort
- The Genome Characterization Centers (GCC) will use state-of-the-art genomics sequencing technologies to identify all types of somatic variation in tissues from the biorepository
- The Data Analysis Center (DAC) will integrate the data generated by the Network to build the variant catalog, portal, and workbench
- The Organizational Center (OC) will coordinate Network activities and establish strong links with related NIH and international programs
- The Technology and Tool Development (TTD) Projects will develop next generation tools focused on significantly improving detection and characterization of somatic variants
To develop this program, the NIH SMaHT Working Group solicited expertise from the biomedical research community through Think Tank Meetings focused on somatic variation, a Request for Information, and meetings with NIH staff and outside experts. Please see the Common Fund’s SMaHT website for the summary of these activities.
The success of this Common Fund Program depends on the formation of a highly interactive, collaborative Network that has the expertise and common vision to create a framework for cataloging somatic variants in a wide variety of post-mortem, non-pathological human tissues. The NIH SMaHT Working Group invites investigators to develop bold, innovative approaches to address the challenges this program will face and that will catalyze our understanding of the role of somatic variants in human health and disease.
Objectives and Scope
This Funding Opportunity Announcement (FOA) invites applications to build and operate a Tissue Procurement Center (TPC) as part of the SMaHT program. This resource will provide high-quality, well-curated human tissues and biological specimens to SMaHT Network investigators, as well as the broader scientific community later in the funding period. The Center will establish a biorepository to rapidly identify, appropriately consent, procure, process, annotate, bank, and distribute a common set of at least 15 high-quality tissues that have no known pathologies (nominally healthy human tissues) from at least 150 post-mortem individuals from a diverse pool of human donors. The Center will be responsible for preservation and rapid distribution of these biospecimens to other funded groups within the SMaHT Network for the generation of foundational genomic datasets to build a comprehensive catalog of human somatic genomic variation across different tissue types and across the lifespan.
It is envisaged that there will be three phases in the development of the TPC. The first year will involve establishing the process for collecting and assessing these tissues using existing biospecimens to troubleshoot and optimize the data generation pipeline within the Network. The second phase will focus on building a SMaHT Network biorepository that will be the foundation of the somatic variant catalog. The third phase will involve ensuring the long term sustainability of the collection and making tissues available to the wider community for complementary analysis.
The Tissue Procurement Center will be heavily involved in collaborative activities within the SMaHT Network. These include: 1) Optimizing the process for collecting high quality tissues in coordination with the Genome Characterization Centers, 2) Working closely with the Data Analysis Center, Organizational Center, and the Network Steering Committee to develop a common metadata schema harmonized with other Common Fund and NIH programs when applicable; 3) Developing Network-wide Material Transfer and Data Use Agreements and coordinating a single IRB and comprehensive informed consent documents for the program, 4) Coordinating and leading the ethical, legal, social implications (ELSI) activities of the Network.
The success of the SMaHT Program depends upon building a Network that can rapidly build a robust and comprehensive catalog of somatic variants in multiple human tissues. The Network will therefore require rapid access to biospecimens for data production activities, and applicants are asked to demonstrate a plan to use existing biospecimens within the first nine months while new tissues are being collected. Applicants are strongly encouraged to leverage existing biorepositories and organ procurement organizations, IT infrastructure, and approvals where appropriate. Applicants are also strongly encouraged to optimize or adapt appropriate solutions and existing resources, tools, and infrastructures, and to create new ones only when required. Centers can propose partnering with existing biorepositories. However, if they do so, they should provide a compelling explanation of why no overlap exists. Programmatic preference will be given to applicants with an established track-record and relevant expertise for collecting and disseminating multiple high-quality tissues from human donors for genomic analysis.
The details for each of the Tissue Procurement Center’s roles are described in more detail below.
Biospecimen Collection and Data Management
The primary objective of the Biospecimen Collection and Data Management Element is the collection and processing of tissue biospecimens according to the standards established by the Steering Committee. The Tissue Procurement Center (TPC) will create a pipeline for rapidly collecting, processing, and distributing a common set of at least 15 tissues from a minimum of 150 donors in a consistent manner. Biospecimens will be taken from a diverse pool of human donors to have approximately an equal representation of males and females across diverse ancestries and the lifespan. The TPC's strategy will be to be flexible because priorities may change during the program based on biological and statistical analysis or datasets needed to complete a catalog.
Specific responsibilities of the center for biospecimen management will include, but are not limited to the following:
- Identifying and enrolling at least 150 tissue donors with no previous medical history of chronic illnesses through an appropriate consenting process; obtaining broad consent for general research use of the collected tissues and explicit consent for genomic data sharing from the donors or family decision makers; creating and managing a centralized database of clinical/phenotypic, environmental exposure data, demographic, family history, and medical history data associated with biospecimens as well as details of their provenance. This metadata should be collected and stored using a common schema with unique identifiers and have a user interface that can be used by the rest of the Network for querying holdings, requesting, and tracking samples.
- Establishing and ensuring consistent implementation of Standard Operating Procedures (SOPs) across collection sites for high-quality tissue collection and processing from various organs to ensure minimization of tissue degradation and maximum reproducibility across donors (e.g., using a Common Coordinate Framework). Collection and processing must meet the quality requirements for various downstream molecular assays for both bulk tissue and single-cell analysis, as well as storage procedures to allow for future derivation of iPSC lines from certain cell/tissue types; establishing QA/QC metrics for ensuring collection, processing, and preservation of nominally healthy tissue biospecimens based on histopathological analysis and standardized tests. Other responsibilities include banking biospecimens for long-term storage using appropriate storage procedures to ensure maintenance of the integrity of the biospecimens and shipping fresh, frozen, or preserved biospecimens rapidly on request to the Network for various molecular analyses using appropriate shipping methods.
- Collecting a common set of at least 15 healthy tissues per donor from a minimum of 150 donors for biobanking and data production. A representative set of tissues from all three germ layers must be collected from each donor. Examples include the following: a) ectoderm-derived tissues/cell-types from brain regions such as hippocampus, cerebral cortex, epidermal layer of exposed and unexposed skin, epithelial layer of oral and nasal cavities, paranasal sinuses, anal canal, etc. b) mesoderm-derived tissues and cell types such as blood, bone marrow, lymphatic tissues, exposed and unexposed skin dermis layer, synovial, smooth muscle, urogenital tissues such as upper vagina and uterus (females) and vas deferens (males); c) endoderm-derived tissues and cell types from ascending and descending colon, trachea or esophagus, lower vagina, spleen, and prostrate; d) reproductive tissues/cells such as ovary, testis, and sperm cells. Additional tissues, including kidney cortex, heart, lung, and liver should be collected when available. Blood samples from each donor should be collected and banked following CLIA-complaint procedures. Applicants should propose a set of representative tissues to reflect several different body systems (and the full range of costs), with rationale for why there is a high probability of complete tissue procurement across 150 donors. However, the final tissue set for this initiative will be finalized after awards are made and result from conversations among the Steering Committee, NIH Staff, and TPC.
- Maintaining data security protection and stewardship of data to ensure confidentiality of donors
- Establishing QA/QC and timeliness metrics and regular auditing plans for effective management of workflows and the biorepository
- Proactively managing communication and coordination with the rest of the Network to provide timely assistance, investigate and adjust workflows if necessary, based on issues raised, and adapt tissue collection strategies based on emerging needs of the Network's efforts to build a catalog.
In addition to this prospective tissue collection, the Center must have access to an existing collection of well-characterized healthy human biospecimens for immediate (e.g., within 3 months) distribution to the Genome Characterization Centers of the SMaHT Network to inform shared experimental design and to serve as a pilot for data generation. The set of tissues chosen should include organs from which larger volumes of tissue can be harvested to meet the demands of the Network
Ethical Legal and Social Implications (ELSI)
Another key responsibility of the Center is to assess the ethical, legal, and social implications (ELSI) of the design, implementation, and results from the SMaHT Network. This work will assist the Network in navigating important issues, adopting best practices, and coordinating with similar programs. It is expected to include consideration of informed consent procedures, sharing research results and incidental findings, the clinical significance of somatic variants, and the value of information to donors, their family members, and their communities.
Specific responsibilities may include but are not limited to:
- Establishing an ELSI framework for the SMaHT program to assess the ethical, legal, and social implications of the Network's activities.
- Assessing effectiveness and adequacy of consent processes for tissue donation, including informing family decision makers of the risks and benefits of the study.
- Creating documentation that can be used to better inform family decision makers, Network members, and the wider research community about ELSI issues.
- Assessing the utility and feasibility of sharing results on known pathogenic variants (per ACMG guidelines) to the families and assess best ways of communicating both research outcomes and incidental findings, as well as appropriate genetic counseling
- Conducting research to develop strategies on how best to communicate the interpretation of somatic variants findings (in one or more tissues) in the context of germline mutations
- Developing strategies for engagement of diverse communities based on an understanding of their concerns around participation
- Understanding the psychological impact on family members who are being asked to participate in the study
- Establishing a Community Advisory Board for the Center to serve as a liaison with donor families and community-based representatives to address expectations, concerns and discuss interpretation of data.
Resource Focus
The success of SMaHT is dependent on establishing a Network that can rapidly build a robust and comprehensive catalog of somatic variants in multiple human tissues. The Tissue Procurement Center will play a central role in collecting the tissues that will form the catalog, and applicants are strongly encouraged to optimize or adapt appropriate existing resources, tools, and infrastructure and to create new ones only when required.
Applications addressing the following topics will be deemed non-responsive and will not be reviewed:
- Centers focused on the collection of pathological tissue or a set of fewer than 15 tissues.
- Centers not proposing to collect tissues from a diverse population of donors for general research use and explicit consent for genomic analysis.
- Centers that do not propose a biospecimen management system that will enable unique identification of biospecimens, metadata sharing, tracking, and rapid dissemination to other SMaHT sites, or
- Projects that do not propose all the required components of the TPC organization or fail to include a detailed Resource Sharing Plan.
Network Coordination and Collaboration
Successful applicants will become members of the larger SMaHT Network composed of investigators who have been funded by one of the SMaHT Network FOAs. A key aspect of this program is the formation of a close partnership amongst all SMaHT awardees aligned around the overarching program goals. All proposals will be asked to include annual goals and milestones that contribute to the overall Network to help achieve this alignment. Shared responsibilities derived from the use of the cooperative agreement mechanism are described later in this FOA and will be further articulated during the kickoff meeting that will take place a few months after awards are made. All funded investigators will be required to attend this initial Kickoff meeting, annual investigator meetings as well as regular teleconferences with Network members and NIH Staff for the duration of the funding cycle.
In addition to completing the research goals outlined in their applications, successful applicants will be expected to work collaboratively with all members of the Network to maximize the success of the program. Therefore, all potential awardees are asked to plan and budget for approximately 20% of their total budget to go towards collaborative activities. Collaborative project activities may include adaptive tissue sampling approaches for regions with high rates of somatic variance, benchmarking of similar methods across sites, comparison of adjacent tissue slices by complementary methods, development of common analytical pipelines and quality assessment metrics, visualization tools or joint analysis of data from the same tissue across multiple donors. Applicants do not need to include these collaborative activities as a separate budget item and are encouraged to include details of potential activities as part of their applications; however, the final set of activities will be determined post-award through discussion with Network members and NIH staff.
NIH intends that the products of the Network be broadly available to the research community to establish the foundations for a somatic variant catalog that other NIH programs and the international community can build upon; this includes methods, tools, reagents, biospecimens, datasets, and software. Awardees will be expected to abide by Network policies such as assay and data standards; the rapid sharing of data, methods, and standards; publication of data and results; partnerships and participation of similar projects and programs and sharing of resources. The robustness and reproducibility of results are critical to the success of SMaHT. In some cases, conducting additional critical validations will be important for assessing progress.
Therefore, NIH Program staff, in consultation with the PD/PI, may modify or add work to be conducted during the duration of an award.
As the Network moves towards realizing its goals, new technologies will become available and unanticipated circumstances will arise. An important aspect of using cooperative agreements to support the Network is the ability to modify metrics, goals, and milestones to respond to opportunities and challenges. Applicants should expect, and applications should anticipate, the need for such flexibility. Any changes in goals will be made with input from NIH Program Staff. It is possible that some changes may, if needed, be accompanied by changes in the distribution of resources within the Network.
Technical Assistance Webinar
All applicants are strongly encouraged to contact NIH Staff to discuss the alignment of their proposed work with the goals of this FOA and the SMaHT Network. A Technical Assistance teleconference will be held for potential applicants from 12-1pm Eastern Time on April 29, 2022. NIH staff will be available to answer questions related to this FOA. Dial in information for the call is posted on the SMaHT website and slides will be made available on the website for those unable to attend. A list of frequently asked questions (FAQs) related to the program are also posted on the website: https://commonfund.nih.gov/smaht. The information session is open to all prospective applicants, but participation is not a prerequisite to apply.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
The Office of Strategic Coordination (Common Fund) intends to commit $3 Million in total costs to fund a single award in FY2023.
Application budgets need to reflect the actual needs of the proposed project.
The project period cannot exceed 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
- Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
- A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
- A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
The letter of intent should be sent to:
Geetha Senthil, Ph.D.
Division of Translational Research
National Institute of Mental Health (NIMH)
Telephone: 301-402-0754
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Facilities and Other Resources: Applications must describe the facilities and resources available. Applicants should especially focus on the unique resources at their institution and any sub-contracts which lend themselves to the completion of the project.
Other Attachments: The following items should be included as other attachments.
Project Management Plan: Applications must provide a Project Management Plan submitted as a single pdf attachment, with the title “Project Management Plan” that includes the following information. Provide a plan detailing the measures that will be taken to ensure cross-disciplinary communication and integration across the team (i.e. the collaborating laboratories) and addressing the division of labor across the team. The plan must provide a detailed description of how different elements of the project would operate in a synergistic and integrated manner. Teams must carefully address how their individual contributions converge on a project that spans the relevant areas of the Center's responsibilities including tissue procurement, quality control, biobanking, data management, and ELSI.
Existing Tissue samples and Data Plan: In this attachment applications must provide detailed description of any available tissue sample and data collections that will be leveraged for this project, including amounts, quality, type, location, procedure for acquiring, etc.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Key personnel are strongly encouraged to highlight in their biosketch experience managing biobanks, including overseeing specimen processing, interacting with a distributed research network, and coordinating ethical, legal, and social implications research.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
PD/PIs: The Center Director must devote a minimum of 1.8 person months of effort to the Center through the individual components. For applications with multiple PDs/PIs, a minimum effort of 1.2 person-month is required for the Contact PD/PI and 1 person-month of effort per additional PD/PI is required.
Program Manager: Based on the complexity of the SMaHT Network, the TPC is strongly encouraged to include and budget for a full-time Program Manager to manage day-to-day operations and work with the Center team, the rest of the Network, and NIH staff to efficiently and effectively manage and coordinate the Centers' activities.
Equipment: If pieces of specialized equipment or computers exceeding $5,000 are requested, the application must provide a clear justification for the purchase in Budget Justification.
Travel: Include travel costs for the Center Director and pertinent members of the Center to attend annual Network investigator meetings and workshops.
Data Analysis: Include details for of data analysis costs beyond routine data management processing and QC. Costs should be limited to less than 15% of the total budget and applicants should note that any proposed cloud computing plans may be modified and consolidated to optimize Network collaboration.
Collaboration: In all years, reasonable costs must be allocated to support shared work with other Network members. Specific tasks will be determined post-award in consultation with NIH staff and a proportion of the award may be restricted pending agreement of goals and milestones.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: Describe the specific goals of the TPC and its role in achieving the overall objectives of the SMaHT Network.
Research Strategy: In the Research Strategy, applicants should propose plans, approaches, and potential alternative strategies for carrying out the goals of the TPC. Applicants are strongly encouraged to highlight their track record in managing biobanks, institutional support for these activities, and any resources, infrastructure or institutional support available for this proposal. The Research Strategy section must consist of a single attachment consisting of subsections A-C, as designated below.
Milestones and Timeline Plan: A timeline (Gantt chart) including milestones is required for each subsection. Milestones are go/no-go decision points in the project and must include clear and quantitative objective criteria for success. Yearly quantitative milestones are required to provide clear indicators of continued progress or emergent difficulties and will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years. The application must include well-defined milestones: e.g., amount of data that will be generated by each data types in each six-month period; expected quality performance measures to be reached each year and criteria for prioritizing selection of biospecimens and incorporating of new technologies.
Subsection A. Resource Overview
Describe the following:
- The overall organizational structure of the Tissue Procurement Center and the details for each component
- The overall experience of the Tissue Procurement Center in handling similar types of projects (i.e., biospecimen procurement from post-mortem donors)
- The collective team expertise and organizational strengths, especially those that are relevant to multi-institutional endeavors
- A leadership plan describing roles, responsibilities, internal decision-making, communication strategies and conflict resolution
- Plans to develop and implement a streamlined administrative process for day-to-day operations of the Center, as well as process to identify and trouble issues with the any element of the Center as appropriate to able to rapidly provide tissue resources to the SMaHT Network
- For this subsection, applicants should define a clear set of semi-annual goals and quantitative milestones with metrics that will logically contribute towards the achievement of the ultimate goals of the SMaHT Network.
Subsection B. Strategy for Biospecimen Management
Describe details on how tissue collection and data management responsibilities will be met in this section, including but not limited to the following:
- Donor recruitment and biospecimen collection: Describe prior experience and/or plans to collaborate with organ procurement organizations and medical examiners to facilitate donor recruitment. Describe plans for donor screening and recruitment along with a proposed timeline and the rapid acquisition of biospecimens for a common set of at least 15 high quality postmortem tissues spanning all three germ layers from a diverse pool of at least 150 human donors from donors with no previous history of chronic illnesses and who have consented for broad/open data sharing
- Describe plans for establishing a rapid and cost-effective pipeline for tissue procurement and distribution through leveraging existing tissue collection sites/resources, adapting existing tools, approaches, procedures, and infrastructure, as well as partnering with existing biorepositories
- Provide rationale for prospective tissue collection based on robust biological/statistical foundations to meet the objectives of the FOA as well as tissue procurement considerations.
- Provide details on existing tissue collection that could be used within the first year of the program to troubleshoot and benchmark the data production pipeline.
- Describe plans on consenting process for tissue donation to allow for general research use of the collected tissues and data, as well as explicit consent for genomic data sharing from the donors or family decision makers
- Diversity of biospecimen collection: Describe plans for acquiring tissues from an approximately equal number of males and females across diverse ancestries and across the lifespan.
- Describe your ability for CLIA-compliant biobanking of whole blood.
- QA/QC measures: Describe plans for developing and implementing standardized and uniform approaches and quality control measures across collection sites for acquiring and storing high-quality tissues needed for various downstream bulk tissue and single-cell molecular analyses (e.g., low post-mortem interval (PMI) and RNA integrity number (RIN) values of >7 for high-quality nucleic acid material).
- Describe the histopathology team and/or plans for comprehensive characterization of biospecimen by histopathology, use of appropriate preservation methods and SOPs:
- Describe plans for optimizing tissue collection processes for various organs including preservation, storage, and shipment of tissues to allow for bulk tissue and single-cell genomic analyses.
- Describe the use of common coordinate frameworks for tissue dissection (if applicable) to minimize source variability across procurement sites.
- Provide details on data collection (clinical, phenotypic, and associated metadata) using acceptable data collection standards.
- Biospecimen distribution: Describe plans for appropriate stabilization, suitable storage, and rapid shipment of a common set of high-quality tissues from each donor, as well as collaborating with the Genomic Characterization Centers on quality measures, biospecimen prioritization, tissue processing, fixation, and shipping methods.
- A process for monitoring tissue collection and distribution pipeline
- An informatics system for maintaining records for biospecimen tracking, storage and distribution, and associated data collection
- For this subsection, applicants should define a clear set of semi-annual goals and quantitative milestones with metrics that will logically contribute towards the achievement of the ultimate goals of the Center
Subsection C. Ethical Legal and Social Implications (ELSI) Strategy
Describe details on how ELSI responsibilities will be met, including but not limited to the following:
- The ELSI team with the appropriate knowledge, expertise, and commitment of effort, to design, implement and analyze the data with regards to tissue collection efforts, as well as SMaHT research studies
- Plans for interaction of the ELSI team with other components of the SMaHT program
- Plans for developing and refining informed consent documentation
- Plans for engaging with diverse communities and stakeholders throughout the program
- Plans to assess family decision makers (FDM) perceptions of the program and the impact of choosing to participate
- Plans for assessing the feasibility of sharing research results with families and how they are best communicated
- Plans for potentially sharing inheritable, actionable results (e.g., pathogenic variants per ACMG guidelines) to family members along with providing access to appropriate genetic counselling
- For this subsection, applicants should define a clear set of semi-annual goals and quantitative milestones with metrics that will logically contribute towards the achievement of the ultimate goals of the Center.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
- All applications, regardless of the amount of direct costs requested for any one year, must address a Resource Sharing Plan.
- Because the ultimate aim of the Program that this RFA is part of is to produce a community resource, the quality of the Resource Sharing Plan will be considered as part of the Approach criterion
- In their Resource Sharing Plan, applicants should indicate their willingness to abide by all policies related to resource sharing developed by the SMaHT Steering Committee and approved by NIH staff. Awardees are expected to develop such policies as members of the Network's Steering Committee in collaboration with NIH and should indicate their willingness to participate in the development of such policies and to abide by them. These policies will remain consistent with NIH policies on data and resource sharing.
- After initial review, NIH program staff will conduct an additional administrative review of the plans for sharing data, software, data analysis, as well as resources and may negotiate modifications of these plans with the prospective awardee. The final negotiated version of these plans will become a term and condition of the award of the cooperative agreement.
The Resource Sharing Plan should include the following sections as appropriate:
- Data Sharing: Implementation of FAIR (Findable, Accessible, Interoperable, Reusable) Principles is essential for the success of SMaHT. Consistent with achieving these principles, the NIH expects that information such as collected data, technical protocols, and any other metadata collected under this FOA is to be rapidly deposited as appropriate into the Data Analysis Center (DAC) and in a recognized and reusable format. The DAC will serve as the central access point for information regarding data, tools, and reagents being developed by the SMaHT Network. Applicants must abide by the NIH Genomic Data Sharing Policy (https://osp.od.nih.gov/scientific-sharing/genomic-data-sharing/) and should indicate their agreement to abide by it in the data sharing plan. The Network will be expected to work closely with the Common Fund Data Ecosystem (https://www.nih-cfde.org/) to assess FAIRness and ensure data and resources from SMaHT are interoperable with other Common Fund resources. In addition, NIH staff will work closely with SMaHT awardees to leverage other NIH initiatives, such as STRIDES (https://cloud.nih.gov/) and the Researcher Auth Service (https://datascience.nih.gov/researcher-auth-service-initiative), to ensure the long-term sustainability of key resources generated by the program beyond its lifetime.
- Public Access: The NIH Common Fund intends to maximize the availability of publications and the sharing of underlying data for the SMaHT Program and encourages publication of preprints and the use of open access journals. Applicants should describe their proposed process for making resulting publications and to the extent possible, the associated data immediately and broadly available to the public or provide a justification if such sharing is not possible. Underlying primary data are expected to be made as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. Applicants are encouraged to use existing, open licensing approaches and preprint repositories, and may include anticipated charges for publication or data sharing and resources that may be needed to support a proposed Resource Sharing Plan in the budget plan of their application.
- Protocol, Tool, and Reagent Sharing: As one of the primary goals of this program is to advance research through development, establishment, broad dissemination and use of community resources across the research community, NIH intends protocols, tools, and reagents generated by the SMaHT Network to be broadly available and distributed at minimal cost, and without undue intellectual property constraints, so that they can be as widely used as possible, thus enabling downstream investigations of understudied biomolecules by the larger scientific community. For all applications and where otherwise applicable, the applicant should discuss plans for sharing and distribution of non-data resources that will be generated by the proposed project, including mathematical models, protocols, biomaterials, and reagents. The DAC will work with all SMaHT teams to collect, curate, and disseminate information regarding tools and reagents being developed to be disseminated through the DAC and other sources as appropriate.
- Biospecimens: In order to maximize the utility of the data, any human biological samples collected and studied or that are derived from existing biospecimens or cell line sources are expected to have been obtained using a documented informed consent process that explicitly allows for future research use and broad data sharing (NOT-HG-20-011). Sources with participant consent for unrestricted access is strongly encouraged. Sources consented for sharing through a controlled-access environment, such as General Research Use (GRU) without additional restrictions, will also be considered and should be well justified. The consent process for human biological samples should be described at a high level in the Research Plan and detailed in the Resource Sharing Plans.
- Intellectual Property: Intellectual property rights asserted by proposers must be aligned with the open-source regime used to distribute software made under the award. Exceptions to open- source technology will be considered only in compelling cases. Awardees will own the software and data developed under this award, subject to the Government’s royalty-free, nonexclusive, irrevocable right to use, disclose, reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, in any manner and for any purpose, and to have or permit others to do so. In addition, inventions, technical solutions, and methods developed under this solicitation will remain the property of the awardees, who may freely use them for their own commercial purposes, subject to a nonexclusive, nontransferable, irrevocable, paid-up license to the Government to practice, or have practiced for or on its behalf, the inventions, technical solutions, and methods throughout the world. Applicants should also be familiar with the NIH statements regarding intellectual property of resources developed with Federal funds (NIH Research Tools Policy (http://grants.nih.gov/grants/intell-property_64FR72090.pdf) and other related NIH sharing policies at http://sharing.nih.gov).
- Sharing Software: Applicants are asked to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others and to have a plan for versioning software. This proposal may include a plan to incorporate the enhancements into the “official” core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution. There is no prescribed single license for software produced in this project; however, the terms of software availability should include the ability of researchers outside SMaHT and its collaborating projects to modify the source code and to share modifications with other colleagues as well as with the SMaHT Network. Reviewers will be asked to evaluate the software sharing and dissemination plan based on its likely impact. Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan. A software sharing plan guided by the following principles is thought to promote the largest impact:
- The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
- The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
- To preserve utility to the community, the software should be transferable such that another individual or team can continue development if the original investigators are unwilling or unable to do so.
Network Participation: Applicants should indicate their willingness to abide by all data deposition, quality control metrics, standardization, metadata requirements, data and software release, and public copyright license policies developed by the SMaHT Network, consistent with NIH-wide policies and approved by NIH staff. A primary goal of the SMaHT is to build a catalog of somatic variants across multiple human tissues, which will require data and resources to be shared quickly and openly once validated, consistent with achieving the goals of the program. Restrictive licensing and sharing practices for SMaHT-generated data, tools, and resources could substantially diminish their value and public benefit. Accordingly, awardees should manage data, resources, protocols, tools, and software in a way that achieves this goal.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Use of Common Data Elements in NIH-funded Research
Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g., genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this FOA:
- What is the likelihood the proposed Center will collect, process, and efficiently distribute a set of at least 15 tissues from at least 150 donors within five years?
- Does the proposed TPC possess capabilities to rapidly distribute these biospecimens to other funded groups within the SMaHT Network (for the generation of foundational genomic datasets to build a comprehensive catalog of human somatic genomic variation across different tissue types and across the lifespan).
- Will the Center address important ELSI challenges that the Network will face and of interest to the research community?
- Is there a clear and realistic vision for how this resource can benefit both the Network and the wider research community?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA:
- Does the team have adequate background and expertise in pathology, laboratory science, and in large-scale biospecimen management/operation, as well as the ability to oversee specimen processing, tracking and customer service?
- How committed is the leadership to addressing the ethical, legal, and social implications of the program's goals?
- Is the leadership plan practical and are internal interactions among the biospecimen management and ELSI elements and external interactions with the rest of the Network adequate?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific to this FOA:
- What is the likelihood that the proposed work will result in improved biorepository practices (e.g., with regard to specimen processing, QA/QC, specimen tracking, or customer service) or otherwise result in a more cost-effective resource or timely biospecimen distribution?
- How do the proposed plans leverage and adapt existing resources and tools and avoid duplication of effort?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this FOA:
- How capable, efficient, and cost-effective is the biobanking operation in collecting, processing, storing, and distributing different types of biospecimens and associated in a timely manner to the Network projects? Are the plans for successful recruitment and collection of at least 15 healthy tissue samples from a minimum of 150 donors from a diverse pool realistic?
- Are the QA/QC efforts appropriate to ensure sufficiently high quality of biospecimens and their annotated data to allow for various downstream molecular analysis and iPSC derivation?
- What is the likelihood that that the data management (e.g., CDEs, data standards, metadata schema, unique identifiers) approach will be realized quickly and be compatible with related programs?
- Does the resource sharing plan adequately address how the applicants will ensure rapid release of data, including metadata, in a way that will be useful to the community?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specific to this FOA:
- Are there existing resources, equipment, and infrastructure available and in place (or readily obtainable) to distribute a set of existing tissue samples to Genomic Characterization Centers within three months, as well as establish procurement pipeline for prospective tissue collection and distribution?
- Are the instrumentation and data science resources in place (or readily obtainable) and adequate to support the project and interactions with the rest of the SMaHT Network?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Is the Project Management Plan adequate and appropriate to ensure coordination of the different elements of the project?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable.
Renewals
Not Applicable.
Revisions
Not Applicable.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
- Evidence of previous productive, cooperative, collaborative interactions as part of a Consortium.
- Evidence that the Center will contribute significantly to the overall goals of the SMaHT program.
- Programmatic balance, including diversity of perspectives and approaches.
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
- Federalwide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
- For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this award will be managed as a cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility reside with the recipients. Specific tasks and activities may be shared among the recipients, within the Network and with NIH staff as defined below.
Definitions
- NIH Working Group (NIH WG): Consists of NIH programmatic staff from multiple Institutes, Centers and Offices of the NIH as well as the Office of the Director. This group will be primarily responsible for the stewardship of the SMaHT Program and will participate as non-voting members in Network committees. The NIH SMaHT WG is led by the Program Coordinator(s) and the Program Leader and co-chaired by the Directors of NIDA, NIEHS, NINDS, NIMH, and NHGRI. It reports to the Directors of the Office of Strategic Coordination / Common Fund and the Division of Program Coordination, Planning, and Strategic Initiatives for final funding decisions.
- SMaHT Program Coordinator(s): One or more NIH Program Staff will serve as Program Coordinators. The SMaHT Coordinator(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role.
- SMaHT Program Leader: The Office of Strategic Coordination will designate a Program Leader to represent the Office of the Director in the WG. The SMaHT Program Leader will have a similar management and oversight role as the program coordinator(s) with specific responsibilities including compliance with NIH Common Fund policies, coordination with other Common Fund programs, and informing the NIH Office of the Director of progress.
- NIH Program Officer: A NIH Program Officer (PO) is responsible for the normal scientific and programmatic stewardship of each award, including monitoring progress and compliance with general statutory, regulatory, or policy requirements; discussing and approving milestones and significant changes to the project; and technical assistance to correct performance and facilitate interactions. The PO must approve in advance and in writing annual milestones and any significant changes to the award. The PO also has the option to recommend to the NIH WG, following consultation with the Project Scientist(s) or EPCs, restricting an award based on progress towards milestones, to incentivize rapid development and implementation of policies or collaboration between members of the Network, or generation of data or resources for use by Network members or the wider community.
- NIH Project Scientist(s): One or more NIH Program Staff will serve as Project Scientists (PSs), for each SMaHT award and, as appropriate, to oversee collaborative projects amongst recipients and/or other Network members. The PS(s) will serve as the scientific representatives of the NIH to the investigators in accordance with the policies and the procedures of the cooperative agreement mechanism. If there is more than one PS, one of them will be designated as the Lead PS. The PS(s) will provide substantial NIH scientific programmatic involvement with the recipient that is anticipated during the performance of the activities supported by this Cooperative Agreement, including review of milestones. PS(s) will work closely with the PD/PI, the Steering Committee, and other NIH resources to maximize progress towards the goals of the project and the program.
- Steering Committee (SC): The purpose of the SC is to recommend direction for the SMaHT Network consistent with the program goals, develop Network policies and projects to build synergy and improve communication and collaboration between the projects, and provide a forum for discussing progress, challenges, and opportunities for the Network.
- External Program Consultants (EPCs): As part of the SMaHT program, NIH staff will engage 5-10 external program consultants (EPCs) not funded as part of the program but with relevant scientific and Network experience to provide input and advice to the NIH WG.
- SMaHT Network: The Network is made up of recipients from the SMaHT FOAs, the NIH WG, and other scientists and groups the SC agrees to include in the Network. The Network structure is meant to efficiently and effectively guide all the funded projects to meet the overall goals of the SMaHT Program.
PD(s)/PI(s) Responsibilities
The PD(s)/PI(s) will have the primary responsibility for:
- Determining research approaches, designing protocols, setting project milestones and timelines, and conducting research.
- Ensuring that the data, software, resources, methods, materials, etc. produced as part of this project are released appropriately and in a timely manner according to NIH and Network Policies
- Preparing abstracts, presentations, reports, and publications in a timely manner.
- Adhering to Network and NIH policies including those related to data and resource sharing, data access, and publications.
- Ensuring proper stewardship of biospecimens, data, documents, and other resources, including not disclosing confidential information, maintaining privacy, and ensuring appropriate use.
- Interacting with other relevant NIH activities, as needed, to promote synergy and consistency among similar or related projects.
- Actively collaborating and sharing information and resources with other members of the Network.
- Ensuring that necessary approvals, including IRB, Data Use Agreement, and Material Transfer Agreement, are obtained in a timely manner.
- Collaborating with the Network to establish data formats, standards, transfer protocols, and transferring data, metadata, and protocols in a timely manner to appropriate databases as defined by the Network.
- Submitting periodic progress or summary reports in a standard format, including data production summaries and metrics of the use and impact on the community
- Abiding by common definitions, protocols, and procedures established by the Network.
- Attending and participating in Network Meetings, including the Steering Committee, Annual Meeting, and working group meetings and accepting and implementing decisions made by the Network.
NIH Responsibilities
The NIH will designate staff, including a Program Officer and Project Scientist(s), to provide stewardship and administrative oversight of the cooperative agreement. Designated staff will be named in the Notice of Grant Award. NIH reserves the right to modify the budget or duration of funding or to curtail an award in the event of: (a) substantive changes in the project not approved in advance, (b) use of funds for activities not within the scope of the specific aims, (c) failure to make sufficient progress toward the project milestones, including timely pre-publication deposition of data or reagents in accordance with approved Network policies, (d) failing to comply with the terms and conditions of the award or establish necessary statutory, regulatory, policy approval required for conducting the project, or (e) ethical or conflict of interest issues.
NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
- NIH staff and their respective Institutes and Centers will manage Conflicts of Interest and Management of Bias as detailed in the NIH Policy Manual.
- The Program Officer is the NIH point-of-contact for the project, except for special circumstances designated by NIH. The Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Program Officer must approve in advance: (i) changes in the roster and effort of the PD(s)/PI(s) and key personnel, (ii) changes in the goals and milestones for the project, (iii) changes in the scientific scope of the project, (iv) changes to the frequency of business meetings, (v) changes in goals of collaborative projects, and (v) any exceptions to the Network’s policies. The Program Officer will not co-author publications with project investigators.
- The Project Scientists(s) will provide advice and guidance to ensure that the project adheres to the objectives of the FOA, the Terms and Conditions of the award, and other agreements between the recipients and NIH. The Project Scientist(s) will keep the PD(s)/PI(s) informed of any issues and concerns involving the project and provide advice on how to address them. The Project Scientist may provide scientific and programmatic assistance to the PD/PI, including contributing to data analysis, key personnel selection, and promoting the availability of data and resources. The Project Scientist(s) will attend all official business meetings of the project's leadership and must be kept informed of all substantive deliberations and developments affecting the project. The Project Scientist(s) will not make decisions about the funding of this project and will not be involved in any special reviews of the project that make recommendations about funding.
- The Program Coordinator(s) and Program Leader will be responsible for program management and oversight, outreach, and budget management for the program. This includes monitoring progress, assessing the effect of the program on the scientific community, proposing revisions to individual awards to meet program goals, developing initiatives, promoting outreach, liaising with other NIH programs, periodically reporting progress to NIH senior management, and meeting regularly with the NIH WG and SMaHT recipients. The Program Coordinator(s) and Program Leader will not co-author publications with project investigators.
- Progress evaluations by the Program Officer, Program Coordinator(s), and Program Leader will be based on the non-competing application and annual project progress report, interim progress reports, and assessments by the Project Scientist(s). The Program Officer, Program Coordinator(s), and Program Leader will review the management, performance, and utilization of the project. If concerns are identified from this review, the Project Scientist(s) will work with the PD(s)/PI(s) to develop plans to address them in the next year of support . In addition, NIH staff may conduct interim reviews of scientific progress beyond the normal yearly non-competing progress review to determine progress and use information from progress reviews to inform future funding for the project.
- Special Reviews. In addition, if concerns are identified about the performance or the management of the project, the Program Officer may conduct special reviews of the project as he/she deems necessary. NIH may engage outside experts to assist in these reviews. If concerns about the project arise and are not resolved, NIH may reduce or restrict the budget or reduce the term of support to phase out the project. In the event of long-term incapacitation of resource facilities, NIH may reduce the budget or term of support to phase out the project. Though the Cooperative Agreement mechanism does provide options for restricting, reducing, or terminating awards, it also provides options for interacting supportively with recipients to help ensure program success. Before any modifications are made, NIH staff will engage with the recipients in a positive manner and as allowed by the Cooperative Agreement mechanism to resolve performance issues where possible in a timely manner.
- External Program Consultants. The EPCs will be senior, scientific experts who are not directly involved in the activities of the and who agree to a confidentiality policy, engaged on an as-needed basis to advise on specific issues. NIH is solely responsible for appointing EPCs for variable durations of service. EPCs are invited to participate in Network meetings and Steering Committees calls and the annual investigators’ meeting. A subset of EPCs may also meet by phone or web at other times of the year, as needed. Annually, the EPCs will provide individual assessments to the NIH of the progress of the Network and will present individual expert recommendations regarding any changes in the program as necessary. The assessments and recommendations will be provided through the NIH WG to the Director of the Office of Strategic Coordination, NIH.
Areas of Joint Responsibility
If there are multiple awards working toward a common goal, close interaction between the participating grantee(s) and NIH staff will be required, to manage, assess, and implement the award(s), goals of the Network, etc. Areas of joint responsibility include:
- Steering Committee (SC): The SC will be the main governing body of the Network. The SC will include PDs/PIs of each of the awards and NIH WG members. The SC will be chaired by two PD/PIs that are approved by the NIH WG. An Executive Committee (EC) composed of the co-chairs and the NIH Program Team Leads will meet to set the agenda for SC meetings and make time-critical decisions on behalf of the Network. The SC may establish subcommittees to oversee the development and implementation of Network policies including data, software, or other releases, publications, and standards, to coordinate analyses, and etc. Subcommittees may be either permanent or time limited, may include additional experts, depending on the needs of the research. The PD(s)/PI(s) will be expected to play an active role in these working groups, as appropriate. It is expected that most of the decisions on the activities of the SMaHT Steering Committee will be reached by consensus. If a vote is needed, each project PD/PI (or Contact PI in the case of multi-PI projects) will have one vote. NIH staff will be non-voting members of the SC. When a vote is required, at least 60% of the quorum will be required for approval. NIH staff will review and approve policies developed by the SC. Recipients will be required to implement policies approved by the SC in a timely manner.
- Responsibilities of the SC will include:
- Ensuring the Network is collegial, collaborative, and representative and activities are consistent with the NIH vision for the program
- Setting research priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted.
- Establishing and monitoring Network policies including policies for data sharing, material sharing, informed consent, tissue collection, publications, and associate membership
- Establishing and implementing data and metadata standards, transfer protocols, quality assessments, and collaborative projects
- Outreach and engagement with the wider research community
- Sharing resources, methodologies, analytical tools, data analyses, preliminary results, etc. in a timely manner
- Generating responses to EPC recommendations
Dispute Resolution
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be addressed by convening a Dispute Resolution Panel. It will be composed of three members: a designee of the SC chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of disagreement for one award, the first member may be chosen by that recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
3. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
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Geetha Senthil, Ph.D.
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Terri Jarosik
National Institute of Mental Health (NIMH)
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Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 2 CFR Part 200, 42 CFR Part 52, and 45 CFR Part 75.
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